Literature DB >> 25229467

Position of the Canadian Association of Gastroenterology on subsequent entry biologics is challenged by biosimilar industry representatives.

Miklos Sebeszta, Alex Kudrin.   

Abstract

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Year:  2014        PMID： 25229467      PMCID： PMC4210237          DOI： 10.1155/2014/347382

Source DB:  PubMed          Journal:  Can J Gastroenterol Hepatol        ISSN： 2291-2789


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  11 in total

1.  International Conference on Harmonisation; guidance on Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process; availability. Notice.

Authors: 
Journal:  Fed Regist       Date:  2005-06-30

2.  Is extrapolation of the safety and efficacy data in one indication to another appropriate for biosimilars?

Authors:  Howard Lee
Journal:  AAPS J       Date:  2013-10-11       Impact factor: 4.009

Review 3.  Overview of subsequent entry biologics for the management of inflammatory bowel disease and Canadian Association of Gastroenterology position statement on subsequent entry biologics.

Authors:  Shane M Devlin; Brian Bressler; Charles N Bernstein; Richard N Fedorak; Alain Bitton; Harminder Singh; Brian G Feagan
Journal:  Can J Gastroenterol       Date:  2013-10       Impact factor: 3.522

4.  Biosimilars in rheumatology: the wind of change.

Authors:  Christian K Schneider
Journal:  Ann Rheum Dis       Date:  2013-03       Impact factor: 19.103

5.  ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD).

Authors:  Silvio Danese; Fernando Gomollon
Journal:  J Crohns Colitis       Date:  2013-04-25       Impact factor: 9.071

Review 6.  Biosimilar monoclonal antibodies: A Canadian regulatory perspective on the assessment of clinically relevant differences and indication extrapolation.

Authors:  Bradley J Scott; Agnes V Klein; Jian Wang
Journal:  J Clin Pharmacol       Date:  2014-06-26       Impact factor: 3.126

7.  ECCO position challenged by European drug regulators.

Authors:  Pekka Kurki; Marie-Christine Bielsky
Journal:  J Crohns Colitis       Date:  2014-02-14       Impact factor: 9.071

8.  Time trends of physician visits for Crohn's disease and ulcerative colitis in the United States, 1960-2006.

Authors:  Amnon Sonnenberg; Joanne Chang
Journal:  Inflamm Bowel Dis       Date:  2008-02       Impact factor: 5.325

9.  Direct health care costs of Crohn's disease and ulcerative colitis in US children and adults.

Authors:  Michael D Kappelman; Sheryl L Rifas-Shiman; Carol Q Porter; Daniel A Ollendorf; Robert S Sandler; Joseph A Galanko; Jonathan A Finkelstein
Journal:  Gastroenterology       Date:  2008-09-17       Impact factor: 22.682

10.  A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study.

Authors:  Dae Hyun Yoo; Pawel Hrycaj; Pedro Miranda; Edgar Ramiterre; Mariusz Piotrowski; Sergii Shevchuk; Volodymyr Kovalenko; Nenad Prodanovic; Mauricio Abello-Banfi; Sergio Gutierrez-Ureña; Luis Morales-Olazabal; Michael Tee; Renato Jimenez; Omid Zamani; Sang Joon Lee; HoUng Kim; Won Park; Ulf Müller-Ladner
Journal:  Ann Rheum Dis       Date:  2013-05-16       Impact factor: 19.103
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